evaluating the device flexitheralight compared to the conventional photodynamic therapy

Conditions: Keratosis, Actinic

Summary: this study compares the efficacy and tolerance of a new device (flexitheralight) for photodynamic therapy in the treatment of keratosis actinic in comparison of classical pdt with aktilite®.

the study is an intraindividual comparison of two methods. the number of subjects to be enrolled is 47 patients. all participants will receive both two treatments in a single visit : a first period of 2.5 hours of illumination with flexitheralight device followed by a continuous red light spectrum (between 7 and 10 minutes) with aktilite® after an appropriate incubation of methyl aminolevulinate). patients will complete a pain assessment scale after receiving both treatments, then, 3 follow up visits will be scheduled.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of minimum 10 previously untreated not pigmented, non-hyperkeratotic ak lesions of grade i and ii of the forehead and/or scalp (according to olsen et al. jaad 1991, cf. ref 31) where other therapies are unacceptable or considered medically less appropriate with a symmetrical repartition on both side of the forehead and/or scalp. the diagnosis of ak will be determined upon clinical evaluation (i.e. visual inspection and palpation) by the investigator. * symmetrical areas in terms of number and severity of lesions. the axis of symmetry between the two areas will be defined by the investigator according to the distribution of lesions. * the two areas to be treated should not be coalescing. a minimum distance of 10mm is required between the lesions located on the 2 symmetrical areas. a minimum distance of 2 mm is required between the lesions on the same side. * minimum 5 lesions with similar dimensions at both symmetrical areas will be treated. if the number of lesions is \>7, only 7 lesions on each side will be considered. exclusion criteria: * patients with porphyria. * patients immunosuppressed for idiopathic, disease specific or therapeutic reasons. * use of topical corticosteroids to lesional areas within 2 weeks before pdt. * patients receiving local treatment (including cryotherapy and curettage, any - patients receiving topical treatment (including imiquimod, 5-fu and diclofenac, picato) in face / scalp area within the last 3 months. * use of topical retinoids or alpha-hydroxy acids, urea or systemic retinoids, chemotherapy or immunotherapy within 4 weeks of pdt. * pigmented ak lesion(s). * known allergy to metvixia, a similar pdt compound or excipients of the cream including arachis oil, or to peanut or soya. * participation in other clinical studies either currently or within the last 30 days. * female subjects must be of either: non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy. * any condition which may be associated with a risk of poor protocol compliance. * patients currently receiving regular ultraviolet radiation therapy

Keywords: pdt, methyl aminolevulinate, light emitting textile